Potentially Problematic Events

Any of the following events must be reported to the Human Subjects Protection Program office within10 business days of the occurrence: New or increased risk, unanticipated harm related to the research, non-compliance, audit or inquiry by a federal agency, failure to follow protocol, breach of confidentiality, change to the protocol to eliminate an immediate hazard, participant unexpectedly becomes a prisoner, unresolved complaint of a subject, or an unanticipated adverse devise effect.  The event must also be reported to the College of Nursing Associate Dean for Research.

1. Complete the Reportable Local Information Items that are Potentially Problematic form. This can be found at http://orcr.arizona.edu/hspp.
   
   
2. Submit the completed form via e-mail to Alice Pasvogel (Office of Nursing Research) at pasvogel@nursing.arizona.edu.
   
   
The Principal Investigator will be notified if additional information is needed.


3. The Office of Nursing Research will obtain the signature of the Departmental Chair or Supervisor and send the documents to the University of Arizona Human Subjects Protection Program.